DeviceClearance

Product code OTX— Physical Medicine

RESTLESS LEG DEVICE

Classification name
Foot Wrap For Treating Restless Leg Syndrome Symptoms
Device class
Class 1
Regulation
21 CFR 890.5760
Advisory panel
Physical Medicine
Total cleared
1
First cleared
Most recent

FDA classification definition

“Applying compression to the muscles of the foot for the purpose of affecting nerve impulses sent to the central nervous system.”

— U.S. Food and Drug Administration, device classification record for product code OTX under 21 CFR 890.5760, via openFDA

Market context for product code OTX

FDA has cleared 1 device under product code OTX, all in 2013, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code OTX

Recent clearances under product code OTX

Data sourced from openFDA. This site is unofficial and independent of the FDA.